Kornimate/medical-research-clean huggingface dataset:
acute heart failure patients with high copeptin treated with tolvaptan targets increased avp activation for treatment (activate)

Conditions: Acute Heart Failure

Summary: patients being hospitalized for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo, based on the level of copeptin measured in their bloodstream. patients with high copeptin levels will be able to participate in the trial, patients with low levels will be excluded. patients being admitted to the observation unit for acute heart failure and already receiving standard therapy will be randomized to receive either tolvaptan or placebo without consideration of the copeptin level. the hypothesis is that patients receiving tolvaptan will have better improvement of shortness of breath than those receiving placebo, within 9 hours of drug administration.


Eligibility criteria:
inclusion criteria: 1. older than or equal to 18 years of age, with diagnosis and planned treatment for acute heart failure 2. dyspnea at rest or minimal exertion per the patient 3. evidence of extracellular volume expansion by at least one of the following: jvd, rales, ascites, edema or positive chest x-ray defined as cardiomegaly, pulmonary vascular congestion, kerley b-lines, pulmonary edema and/or pleural effusion. 4. elevated bnp level \>200 pg/ml, or ntprobnp \> 1000pg/ml 5. able to administer study drug within 8 hours from triage time inpatient hospitalized inclusion only: co-peptin level \> 27 pmol/l exclusion criteria: 1. unable to provide informed consent 2. unable to have 30 day telephone follow up 3. not expected to survive past 6 months 4. on renal replacement therapy or creatinine \>3.5 5. history of allergy or intolerance to tolvaptan 6. suspected pregnancy 7. cardiogenic shock 8. participation in any interventional trial in prior 30 days. 9. receiving or planned to receive iv inotropic therapy 10. acs now or in the past 30 days 11. treatment with iv infusion vasoactive drugs in the hour prior to enrollment 12. temperature \> 100.5 13. heart failure due to atrial fibrillation with rapid ventricular response 14. sbp \< 90 mmhg

Keywords: acute heart failure emergency department copeptin adh antagonists
3d camera - telemedical foot ulcer treatment

Conditions: Diabetes Mellitus; Foot Ulcers

Summary: diabetic foot ulcers are deep wounds that occur as a result of nerve damage in the feet (peripheral neuropathy). amputation is a common consequence of diabetic foot ulcers; approximately 85% of all diabetes-related amputations are caused by foot ulcers. the ulcer treatment is extensive, resource demanding and highly specialized and necessitates involvement of patient, hospital and local in-home care personnel. the 3d photo optic camera project aims at a much more efficient and precise method for diagnosis and treatment of foot ulcers. the department of endocrinology and the section for lean and innovation at odense university hospital has developed a prototype for a 3d camera that takes pictures and measurements of the ulcer that can provide the basis for correct diagnosis and treatment of the ulcer. the camera was developed in close cooperation with teccluster a/s, svendborg municipality, team online and commed.


Eligibility criteria:
inclusion criteria: * patients with diabetic foot ulcers, which has been the diagnosis, stratification (eg ischemia, neuropathy, etc.) and treatment according to current guidelines refer "diabetic foot study group". age 18-90 years exclusion criteria: * superficial wounds (superficial skin defect with loss of substance in 5 x 5 mm)

Keywords: telemedicine diabetes foot ulcers
a study to evaluate the efficacy and tolerability of rizatriptan for treatment of acute migraine in children and adolescents (mk-0462-082 am7)

Conditions: Migraine, Acute

Summary: this clinical trial evaluates the safety and efficacy of rizatriptan for the acute treatment of migraine in children and adolescents.


Eligibility criteria:
inclusion criteria: * patient weighs at least 20 kg (44 pounds) * patient has had a history of migraine with or without aura \> 6 months with \>= 1 to \<= 8 moderate or severe migraine attacks per month in the 2 months prior to screening visit 1 * patient has a history of migraine defined by international headache society (ihs) migraine definitions * patient is willing to stay awake for at least 2 hours after administration of the first dose of study medication * patient has not experienced satisfactory relief from migraine pain with nonsteroidal anti-inflammatory drugs (nsaids) or n-acetyl-p-aminophenol (apap) treatment * the parent or guardian and patient agree to the patient's participation in the study as indicated by parental/guardian signature on the consent form and patient assent - for patients taking migraine prophylactic medication, treatment regimen is stable and has been taken for at least 3 months prior to visit 1. exclusion criteria: * patient is pregnant or breast-feeding, or is a female expecting to conceive within the projected duration of study participation * patient has a history of mild migraine attacks or migraines that resolve in less than 2 hours * patient has basilar or hemiplegic migraine headaches * patient has \>15 headache-days per month or has taken medication for acute headache on more than 10 days per month in any of the 3 months prior to screening * patient has uncontrolled high blood pressure, uncontrolled diabetes, human immunodeficiency virus (hiv), any cancer, or any other significant disease * patient has a history or clinical evidence of cardiovascular problems or stroke * patient has either demonstrated hypersensitivity to or experienced a serious adverse event in response to rizatriptan * patient did not experience satisfactory relief from migraine pain to prior treatment with 2 or more adequate courses of 5-hydroxytryptamine 1 (5ht1) agonists * patient has a recent history (within the past year) or current evidence of drug or alcohol abuse or is a "recreational user" of illicit drugs * patient is currently taking monoamine oxidase inhibitors, methysergide, selective serotonin reuptake inhibitors (ssris) or serotonin norepinephrine reuptake inhibitors (snris) or propranolol, and is unable to tolerate withdrawal of these medications for the intervals required * patient is currently participating or has participated in a study with an investigational compound or device within 30 days of screening - patient is legally or mentally incapacitated.
a phase 2a study to assess safety, daily symptoms, pk, and biomarkers of ypl-001 in copd patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this is a phase 2a, proof-of-concept, multicenter, randomized, double-blind, double dummy, 3-treatment, parallel study, with low and high ypl 001 doses (low dose and high dose twice daily \[bid\]) and a placebo control in moderate to severe chronic obstructive pulmonary disease (copd) patients.

treatments are described as follows: treatment a: multiple oral ypl-001 80 mg doses (1 x 80 mg tablet + 1 x 1 ypl-001 80 mg matching placebo tablet) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days. only the morning dose will be administered on day 56. treatment b: multiple oral ypl-001 160 mg doses (2 x 80 mg tablets) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days. only the morning dose will be administered on day 56. treatment c: multiple oral matching placebo (2 x 1 ypl-001 80 mg matching placebo tablets) will be administered approximately every 12 hours under fasting conditions for 55 consecutive days. only the morning dose will be administered on day 56. in all treatments, one tiotropium (spiriva® handihaler®) 18 μg capsule will also be administered qd every morning prior to study drugs administration. albuterol will be administered on an as needed basis. each dose of treatments a, b and c will be administered orally with approximately 240 ml of water.

Eligibility criteria:
inclusion criteria: * adult males and/or females, 30 to 85 years of age (inclusive). * history of copd for at least 12 months prior to screening. * diagnosed with copd as defined by the american thoracic society (ats)/european respiratory society (ers) guidelines with symptoms compatible with copd for at least 12 months prior to screening. * classified as moderate to severe copd based on the current severity classification gold stage 2-3 disease in terms of post-bronchodilator spirometry at screening * etc. exclusion criteria: * history of life-threatening copd including respiratory arrest, intensive care unit admission and/or requiring intubation. * history of more than 2 hospitalizations for copd within 12 months prior to screening. * presentation of an acute exacerbation of copd that will be associated with increase sputum volume or change in sputum color within 4 weeks before day 1 of the run-in period. * evidence of pulmonary heart disease, or clinically significant pulmonary hypertension. * etc.

Keywords: copd
18f-f-arag pet imaging to evaluate immunological response to car t cell therapy in lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: this is a pilot study in adult subjects with aggressive b-cell lymphoma who will receive commercial or research car t cell therapy as anticancer treatment.

primary objectives: \* explore the relationship of change in \[18f\]f-arag pet signal following car t cell treatment with changes in t cell infiltration in tumor biopsies. exploratory analyses: * explore the relationship of change in \[18f\]f-arag pet signal in tumor lesions following car t cell treatment with clinical benefit rate (defined as complete response (cr) + partial response (pr) + stable disease (sd) ≥ 3 months) using recistv1.1 criteria * correlate the change in \[18f\]f-arag pet signal in tumor lesions following car t cell therapy with maximum grade of cytokine release syndrome (crs) and neurotoxicity experienced.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * histologically confirmed aggressive b cell nhl including the following types defined by who 2008: * dlbcl not otherwise specified; t cell/histiocyte rich large b cell lymphoma; dlbcl associated with chronic inflammation; epstein barr virus (ebv)+ dlbcl of the elderly; or * primary mediastinal (thymic) large b cell lymphoma * transformation of follicular lymphoma, marginal zone lymphoma or chronic lymphocytic leukemia to dlbcl will also be included * measurable disease by pet imaging (as defined by cheson (2014)), that meets all the following criteria: * at least one measureable lesion away from head \& neck, liver, kidneys, gi tract and bladder * at least one biopsy-accessible lesion or lymph node. * express willingness to undergo low risk fna or core biopsy of subcutaneous accessible lesion or lymph node. * scheduled to receive commercial or research car t cell therapy with axicabtagene ciloleucel (yescarta ®) as part of anticancer therapy. * adequate renal and hepatic function, defined as: 1. creatinine clearance (as estimated by cockcroft gault) ≥ 60 ml/min or cr \< 1.6 mg/dl 2. serum alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≤ 2.5x upper limit of normal (uln) 3. total bilirubin ≤ 1.5 mg/dl, except in cases of gilbert's syndrome * able to give informed consent. subjects unable to give informed consent will not be eligible for this study exclusion criteria: * women who are pregnant or breastfeeding. * subjects with significant gi disease involvement by pet imaging * in the investigator's judgment, have any medical condition likely to interfere with assessment of safety or efficacy, be unable to tolerate additional radiation, or be unlikely to complete all protocol-required visits and procedures.
contribution of animal-assisted intervention in oral healthcare for disabled patients (yoda)

Conditions: Autism

Summary: the purpose of this study is to determine whether animal-assisted therapy during 2 care sessions then facilitates conventional ambulatory management without animal assistance in anxious uncooperative children with autism.

the particularity of some disabled patients, especially those with an autism spectrum disorder, is represented by anxiety, which can range from a slight tension to screaming or even extreme agitation. this behavior can make therapeutic management difficult, both for the patient and the caregiver. this is particularly true for oral health care, where the cooperation of the patient is essential. conventional behavioral approaches, with implementation of a multitude of adaptive strategies, has a fundamental role to play. with disabled patients, these techniques are most often based on non-verbal or para-verbal communication rather than on linguistic procedures. in this context, an animal assisted intervention could be of major help. the primary outcome is average child anxiety during the session assessed by the venham scale modified by veerkamp measured at the end of the third session of care (without animal-assisted therapy).

Eligibility criteria:
inclusion criteria: * minors aged ≥ 6 to ≤ 17 years, * carriers of autism spectrum disorder. * child with an average venham scale score ≥ 3 at the end of the care of the inclusion session * who accept the presence of the dog * who declare having been in contact with a dog in the past * consent from the child's legal guardians for the child's participation in the study, * be affiliated to a social security scheme in their own name or be the legal guardian of a person with parental authority. * a state of health requiring a simple, non-complex dental procedure (preventive, carious, traumatic or orthodontic care, excluding complex surgery in the operating theatre) * a state of health requiring a dental treatment protocol consisting of at least 3 scheduled treatment sessions spaced at least 7 days and no more than 21 days apart. exclusion criteria: * child with dog allergy * cynophobia * who claims never to have been exposed to a dog (allergy risk not assessed) * patient on ame

Keywords: animal-assisted therapy child autism
effect of rosuvastatin therapy in patients with stable chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this study is to investigate whether rosuvastatin improves measures of endothelial function, decreases measures of inflammation, and improves pulmonary function in patients with stable chronic obstructive pulmonary disease.


Eligibility criteria:
inclusion criteria: * stable copd patients of both genders with no copd exacerbations less than three weeks prior to inclusion * copd stage i to iv after the gold criteria (global initiative for chronic obstructive lung disease) * age between 40 and 80 years exclusion criteria: * diagnosed lung disease other than copd, except chronic asthmatic bronchitis and mild bronchiectasis without or few physical signs (diagnosed by high resolution ct) * history of or active coronary artery disease (cad), cerebrovascular or peripheral vascular disease * history of or clinically significant congestive heart failure, valvular heart disease, clinically significant arrhythmias or conduction delays * history of uncontrolled arterial hypertension (defined as blood pressure above180/110 mmhg with or without the use of antihypertensive medication) * body mass index \>40kg/m2 * history of diabetes mellitus, measured fasting glucose \> 11 mmol/l * history of hypercholesterolemia, measured total cholesterol \> 8 mmol/l * known poliomyelitis, motor neurone disease, cranial or temporal arteritis, stroke or myopathy * neutropenia, anemia (hb \< 8 g/100ml) * history of chronic renal failure, serum creatinine \> 176 micromol/l (2.0mg/dl) * creatine kinase \> 3 times the upper limit of normal (uln) * acute or chronic liver disease (serum transaminases \> 3 times the uln) * pregnancy (oral examination and blood test prior to inclusion) * active abuse of drugs or alcohol, poor compliance anticipated * statin use within the last 4 weeks prior to study start or previously clear indication for statin use * prior diagnosis of statin induced myopathy or hypersensitivity reaction to another hydroxymethylglutaryl-coenzyme a-reductase inhibitor incl. rosuvastatin * history of malignant disease of any kind within 5 years prior to inclusion. * history of uncontrolled hypothyroidism * participation in another pharmaceutical or medical device clinical trial study less than 4 weeks prior inclusion. * use concomitant of medications that are known to interact with crestor. this includes the following medications: warfarin and other coumarin (vitamin k antagonist) anticoagulants, cyclosporin, gemfibrozil and antacid

Keywords: inflammation atherosclerosis hydroxymethylglutaryl-coenzyme a reductase inhibitors
registry of deep brain stimulation with the vercise™ system: vercise dbs registry

Conditions: Parkinson's Disease

Summary: the purpose of this registry is to compile characteristics of world-wide outcomes for the use of boston scientific's commercially available vercise dbs system in the treatment of parkinson's disease. the utilization of image guided programming (igp), and other commercially available programming features, used as planning tools for the programming of patients with boston scientific's vercise dbs system are also evaluated. additionally, the utilization of the dbs illumina 3d feature that may be used for the programming of patients with boston scientific's vercise dbs systems is also evaluated.

the purpose of this registry is to compile characteristics of world-wide outcomes for the use of boston scientific's commercially available vercise dbs system in the treatment of parkinson's disease. subjects' improvement in disease symptoms and overall quality of life will be assessed during the study following dbs and compared with baseline. additionally, the utilization of image guided programming (igp) when used as a planning tool for programming of patients is also evaluated.

Eligibility criteria:
key inclusion criteria: * meets criteria established in locally applicable vercise system direction for use * at least 18 years old key exclusion criteria: * meets any contraindication in the vercise system locally applicable directions for use subjects with significant cognitive or psychiatric impairment may be excluded in the evaluation of gxt.

Keywords: deep brain stimulation parkinson's disease vercise
alfuzosin and mirabegron for double-j stent symptoms

Conditions: Ureteral Stent-Related Symptoms

Summary: this prospective randomized controlled trial investigates the effects of alfuzosin, mirabegron, and their combination on stent-related symptoms and outcomes in patients undergoing dj stent placement after retrograde intrarenal surgery (rirs) for renal stones. the primary outcomes include stone-free rate and residual fragment status, while secondary outcomes focus on stent-related pain and lower urinary tract symptoms (luts). patients will be randomly assigned to one of four groups: alfuzosin only, mirabegron only, combination therapy, or control. pain and luts will be assessed using validated questionnaires such as the ureteral stent symptom questionnaire (ussq) and ipss.

retrograde intrarenal surgery (rirs) is a commonly used minimally invasive procedure for the treatment of renal stones. postoperative placement of double-j (dj) stents is often necessary but can result in significant stent-related discomfort and lower urinary tract symptoms (luts), which negatively impact patient quality of life. alfuzosin, an alpha-blocker, and mirabegron, a beta-3 agonist, are pharmacological agents known to reduce stent-related symptoms. this study aims to compare the individual and combined efficacy of these agents on stent-related pain, luts, and postoperative stone outcomes. patients will be evaluated for stone clearance, residual fragments (by imaging), and symptom scores over a follow-up period of 2 to 4 weeks post-rirs

Eligibility criteria:
inclusion criteria: - undergoing rirs and dj stenting ability to provide informed consent exclusion criteria: * neurogenic bladder prostate volume \>40 ml or significant luts at baseline contraindications to alpha-blockers or mirabegron hepatic or severe renal impairment

Keywords: nephrolithiasis ureteral stent-related symptoms lower urinary tract symptoms postoperative pain retrograde intrarenal surgery
avonex® combination trial - "act"

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the purpose of this study is to determine the efficacy and safety of combination therapy with avonex plus low dose oral methotrexate (mtx), every other month courses of intravenous methylprednisolone (ivmp), or both in patients with continued disease activity on avonex monotherapy.


Eligibility criteria:
inclusion criteria: * age 18 to 55, inclusive * diagnosis of ms * a relapsing-remitting course * expanded disability status scale (edss) score 0.0-5.5 inclusive at baseline * currently receiving avonex® therapy * treated with avonex® for at least 6 consecutive months prior * breakthrough disease (clinical relapse or gadolinium-enhancing mri lesion) during the prior 12 months, at least 6 months after initiating avonex therapy. exclusion criteria: * history of cirrhosis, chronic hepatitis, or currently active hepatitis * history of poorly-controlled hypertension, diabetes mellitus, or peptic ulcer disease * history of aseptic bone necrosis, osteoporosis, or osteoporosis-related bone fracture * history of steroid-induced psychosis. * history of or abnormal laboratory results indicating significant illness * history of severe allergic or anaphylactic reactions or known drug hypersensitivity or intolerance to mtx, ivmp, or avonex®. * history of allergy to albumin * history of any episode of suicidal ideation or severe depression within 3 months of the screening visit. * history of seizure within 3 months prior to the screening visit. * diagnosis of primary progressive, secondary progressive, or progressive relapsing ms * ms relapse with onset within 60 days prior to the baseline visit * any metallic or electronic material or device in the body, or condition that precludes the subject from undergoing mri with gadolinium administration * a clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days of the screening visit * abnormal blood tests, performed at the screening visit, which exceed any of the limits defined by the study.

Keywords: multiple sclerosis relapsing-remitting avonex combination methotrexate iv methylprednisolone ivmp act mtx
a therapeutic exploratory clinical study of da-8010 in patients with overactive bladder

Conditions: Overactive Bladder

Summary: a therapeutic exploratory clinical study to evaluate the efficacy and safety of da-8010 in patients with overactive bladder and to determine the optimal dose of da-8010


Eligibility criteria:
inclusion criteria: main inclusion at screening (visit 1): * men and women 19 years or older with oab symptoms for ≥ 3 months. * subject who is willing and able to complete the micturition diary correctly. * subject who is willing and able to provide informed consent indicating that they understand the purpose and procedures required for the study exclusion criteria: * clinically significant stress urinary incontinence or mixed urinary incontinence where stress is the predominant factor * diagnosed with interstitial cystitis or bladder pain syndrome * clinically significant pelvic organ prolapse * subject who has neurologic status which is able to effect vesical function, such as multiple sclerosis, spinal injury or parkinson's disease * medical history of malignant tumor in urinary system or pelvic organs * clinically significant bladder outlet obstruction or more than 200ml of post-void residual volume